Associated Press/Philadelphia Inquirer—December 8, 2011
The Food and Drug Administration's panel of experts voted 21-5 Thursday that labeling on the popular drugs made by Bayer is inadequate and needs more information about the potential risk of blood clots in the legs and lungs.
Panelists spent more than nine hours discussing often conflicting data on the blood clot risk of drospirenone-containing drugs compared with older medications. While the group disagreed on the quality of the evidence, the overwhelming majority said it should be clearly stated in the label, including the potentially fatal nature of blood clots.
"Clearly the wording is inadequate and incomplete," said Dr. Richard Bockman of New York's Hospital for Special Surgery. "Adverse events have to be made graphic so physicians and patients are aware of the consequences."